The study design is presented in eFigure 1 in Supplement 2 . The trial consisted of a screening period, a washout period of 36 hours (if participants were previously taking an angiotensin-converting enzyme inhibitor), and a randomized, double-blind, double-dummy, treatment period including dose titration in 2 arms. The intervention arm received sacubitril/valsartan starting at 49 mg/51 mg twice daily, titrated after 2 weeks to 97 mg/103 mg twice daily in addition to usual medical care and a valsartan dummy. The active control arm received valsartan, 80 mg twice daily, titrated after 2 weeks to 160 mg twice daily in addition to usual medical care and a sacubitril/valsartan dummy.
Lower starting doses were used for patients with low systolic blood pressure (SBP; ≥100 mm and <110 mm Hg) or on low or no dose of angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker at the baseline visit. Full details of the medication manufacture, randomization, blinding, allocation concealment, and titration protocol are in eMethods 2 and eTable 2 inSupplement 2 .
Lower starting doses were used for patients with low systolic blood pressure (SBP; ≥100 mm and <110 mm Hg) or on low or no dose of angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker at the baseline visit. Full details of the medication manufacture, randomization, blinding, allocation concealment, and titration protocol are in eMethods 2 and eTable 2 in
Free full text: Click here
